Xpert CT/NG

K173840 · Cepheid · LSL · Mar 16, 2018 · Microbiology

Device Facts

• Record ID: K173840
• Device Name: Xpert CT/NG
• Applicant: Cepheid
• Product Code: LSL · Microbiology
• Decision Date: Mar 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3390
• Device Class: Class 2

Intended Use

The Xpert® CT/NG Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).

Device Story

Xpert CT/NG Assay is an automated, multiplex real-time PCR test for qualitative detection/differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae DNA. Input samples include urine, endocervical swabs, and patient-collected vaginal swabs. The device uses single-use disposable cartridges containing PCR reagents; the GeneXpert Instrument System automates sample purification, nucleic acid amplification, and target sequence detection. The system includes an instrument, PC, and preloaded software. Modules feature a syringe drive for fluidics, ultrasonic horn for cell/spore lysis, and I-CORE thermocycler for PCR. Output is a qualitative result provided to clinicians to aid in diagnosing urogenital infections. The device is used in clinical settings; it benefits patients by providing rapid, automated diagnostic results to guide treatment decisions.

Clinical Evidence

The device relies on clinical data from the predicate (K121710). A reanalysis of clinical study data from K121710 was performed specifically for specimens collected from pregnant women to support the removal of a previous performance limitation.

Technological Characteristics

Multiplex real-time PCR; 5' exonuclease detection. Includes internal controls: Sample Processing Control (SPC), Sample Adequacy Control (SAC), and Probe Check Control (PCC). Form factor: single-use disposable cartridges. Instrument: GeneXpert System (Dx, Infinity-48, Infinity-80). Connectivity: wired data transmission to PC. Software: preloaded system software.

Indications for Use

Indicated for symptomatic and asymptomatic individuals, including pregnant women, for the qualitative detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in female/male urine, endocervical swabs, and patient-collected vaginal swabs to aid in the diagnosis of urogenital disease.

Regulatory Classification

Identification

Neisseria spp. direct serological test reagents are devices that consist of antigens and antisera used in serological tests to identify Neisseria spp. from cultured isolates. Additionally, some of these reagents consist of Neisseria spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) which may be used to detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans by indirect methods, such as detection of antibodies or of oxidase produced by gonococcal organisms.

Predicate Devices

• Xpert® CT/NG (K121710)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 27, 2018

Cepheid Jim Kelly, Ph.D. Executive Director, Regulatory Affairs 904 Caribbean Drive Sunnyvale, California 94089

Re: K173840

Trade/Device Name: Xpert CT/NG Regulation Number: 21 CFR 866.3390 Regulation Name: Neisseria spp. direct serological test reagents Regulatory Class: Class II Product Code: LSL, MKZ, OOI, LIO Dated: December 15, 2017 Received: December 18, 2017

Dear Jim Kelly:

This letter corrects our substantially equivalent letter of March 16, 2018.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Uwe Scherf -S

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173840

Device Name Xpert CT/NG

#### Indications for Use (Describe)

The Xpert CT/NG Assay, performed on the GeneXpert Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).

Ancillary Collection Kits:

Xpert Vaginal/Endocervical Specimen Collection Kit

The Cepheid Xpert Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

Xpert Urine Specimen Collection Kit

The Cepheid Xpert Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| | <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> |
|--|-----------------------------------------------------------------------------------------------------------|
| | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary

As required by 21 CFR Section 807.92(c).

| Submitted by: | Cepheid<br>904 Caribbean Drive<br>Sunnyvale, CA 90489<br>Phone number: [phone]<br>Fax number: [phone] |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Kelly, Ph.D. |
| Date Submitted: | February 13, 2017 |
| Device: | |
| Trade name: | Xpert® CT/NG |
| Common name: | Xpert CT/NG Assay |
| Type of Test: | Automated, multiplex real-time polymerase chain reaction<br>(PCR) assay intended for the in vitro qualitative detection and<br>differentiation of DNA from Chlamydia trachomatis (CT)<br>and/or Neisseria gonorrhoeae (NG). |
| Regulation Number<br>Classification Name: | 21 CFR 866.3390 Neisseria spp. direct serological test reagents<br>21 CFR 866.3120 Chlamydia serological reagents<br>21 CFR 862.2570 Instrumentation for clinical multiplex systems<br>21 CFR 866.2900 Microbiological specimen collection and<br>transport device |
| Regulatory<br>Classification | II |
| Product code: | LSL: DNA-Reagents, Neisseria<br>MKZ: DNA Probe, Nucleic Acid Amplification, Chlamydia<br>OOI: Real Time Nucleic Acid Amplification System<br>LIO: Device, Specimen Collection |
| Classification<br>Advisory Panel | Microbiology (83) |
| Prescription Use | Yes |
| Predicate Device: | Xpert® CT/NG<br>[510(k) #K121710] |

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#### Device Description:

The Xpert CT/NG Assay is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG). The assay is performed on the Cepheid GeneXpert Instrument Systems. The Xpert CT/NG Assay on the GeneXpert Instrument System automates and integrates sample purification, nucleic acid amplification and detection of the target sequences in simple or complex samples using real-time PCR. The system consists of an instrument, personal computer, and preloaded software for running the tests and viewing the results. The system requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, crosscontamination between samples is minimized.

The Xpert CT/NG Assay includes reagents for the detection and differentiation of CT and NG. A Sample Processing Control (SPC), a Sample Adequacy Control (SAC), and a Probe Check Control (PCC) are also included. The SPC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the PCR reaction. The SAC reagents detect the presence of a single copy human gene and monitor whether the specimen contains human cells. The PCC verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability.

The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems, the GeneXpert Infinity-48 System and the GeneXpert Infinity-80 System, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and detection.

The ancillary specimen collection kits for use with the Xpert CT/NG Assay are the Cepheid® Xpert® Vaginal/Endocervical Specimen Collection kit and the Cepheid® Xpert® Urine Specimen Collection kit.

### Device Intended Use:

The Xpert® CT/NG Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).

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Ancillary Collection Kits:

Xpert Vaginal/Endocervical Specimen Collection Kit

The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

# Xpert Urine Specimen Collection Kit

The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.

# Substantial Equivalence:

The Xpert CT/NG Assay is substantially equivalent to the predicate device, Cepheid Xpert CT/NG Assay [510(k) # K121710, cleared on December 27, 2012].

Table 8-1 shows the similarities and differences between the Xpert CT/NG Assay and the predicate device.

| Similarities | | |
|--------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device | Predicate Device |
| | Cepheid Xpert CT/NG Assay | Cepheid Xpert CT/NG Assay |
| 510(k) Number | To be assigned | K121710 |
| Regulation | Same | 866.3390, 866.3120 |
| Product Code | Same | LSL, MKZ |
| Device Class | Same | II |
| Technology/<br>Detection | Same | Multiplex real-time<br>polymerase chain reaction<br>(PCR) |
| Intended Use | Same | The Xpert® CT/NG Assay,<br>performed on the GeneXpert®<br>Instrument Systems, is a<br>qualitative <i>in vitro</i> real-time<br>PCR test for the automated |
| Similarities | | |
| Item | Device | Predicate Device |
| | Cepheid Xpert CT/NG Assay | Cepheid Xpert CT/NG Assay<br>detection and differentiation of genomic DNA from<br><i>Chlamydia trachomatis</i> (CT)<br>and/or <i>Neisseria gonorrhoeae</i> (NG) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting).<br><br>Ancillary Collection Kits:<br>The Cepheid® Xpert® Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve, and transport <i>Chlamydia trachomatis, Neisseria gonorrhoeae</i> , and <i>Trichomonas vaginalis</i> DNA in endocervical swab specimens (collected by a clinician) and patient-collected vaginal swab specimens (collected in a clinical setting) from symptomatic and asymptomatic women prior to analysis with the Xpert CT/NG Assay and the Xpert TV Assay.<br><br>The Cepheid® Xpert® Urine Specimen Collection Kit is designed to preserve and |

# Table 8-1: Comparison of Similarities and Differences of the Xpert CT/NG Assay with the Predicate Device

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| Similarities | | | | |
|--------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Item | Device | Predicate Device | | |
| | Cepheid Xpert CT/NG Assay | Cepheid Xpert CT/NG Assay | | |
| | | gonorrhoeae, and<br>Trichomonas vaginalis DNA<br>in first-catch female and male<br>urine specimens from<br>symptomatic and<br>asymptomatic individuals prior<br>to analysis with the Xpert<br>CT/NG Assay and the Xpert<br>TV Assay. | | |
| Indication for Use | Same | Asymptomatic and<br>symptomatic patients | | |
| Assay Targets | Same | DNA from Chlamydia<br>trachomatis (CT) and/or<br>Neisseria gonorrhoeae (NG) | | |
| Specimen Type | Same | Urine, endocervical swab, and<br>patient-collected vaginal swab<br>(collected in a clinical setting) | | |
| CT Analyte Targets | Same | CT genomic DNA | | |
| NG Analyte Targets | Same | NG genomic DNA | | |
| Collection Kit | Same | Urine collection kit<br>Swab collection kit | | |
| Nucleic Acid<br>Extraction | Yes | Yes | | |
| Assay Results | Same | Qualitative | | |
| Instrument System | Same | Cepheid GeneXpert<br>Instrument System | | |
| Assay Controls | Same | Internal sample processing<br>control (SPC), sample<br>adequacy control (SAC), and<br>probe check control (PCC).<br>External controls available. | | |
| Time to obtain test<br>results | Same | Approximately 90 minutes (1.5<br>hours) to results. | | |

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| Primary Differences | | |
|---------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | Device | Predicate Device |
| Item | Cepheid Xpert CT/NG Assay | Cepheid Xpert CT/NG Assay |
| Limitation | Xpert CT/NG Assay<br>performance has not been<br>evaluated in patients with a<br>history of hysterectomy. | Xpert CT/NG Assay<br>performance has not been<br>evaluated in pregnant women,<br>or in patients with a history of<br>hysterectomy. |

The Xpert CT/NG Assay has the same intended use as the predicate device and has the same technological characteristics as the predicate device.

# Non-Clinical Studies:

# Analytical Sensitivity

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information.

# Analytical Reactivity (Inclusivity)

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information.

# Analytical Specificity (Exclusivity)

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information.

### Interfering Substances

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information.

# Carry-Over Contamination Study

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information.

### Linearity

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information.

### Clinical Performance Characteristics:

### Reproducibility and Precision

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information.

### Clinical Performance Study

Please refer to the previously FDA-cleared 510(k) #K121710 for additional information. Reanalysis of the clinical data from 510(k) #K121710 was performed for the specimens collected from women who were pregnant at the time of collection.

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# Conclusions

The intended use and fundamental scientific technology of the Xpert CT/NG Assay is the same as the legally marketed Xpert CT/NG Assay. The reanalysis of the clinical study data from K121710 supports the removal of the limitation statement for the pregnant women. The Xpert CT/NG is substantially equivalent to the predicate device.